GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries

• Status: Enrolling by invitation
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Anesthetics; Anesthetics, General

Criteria

Inclusion Criteria:

• Patients from the ages 18- 80 years

• Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels.

• Able to follow study protocol

• Able to provide informed consent

Exclusion Criteria:

• Surgery with planned need for postoperative surgical drain.

• Allergies of contraindication to any study anesthetic or analgesic medications.

• Morbid obesity, defined as BMI > 35 kg/m2.

• Involved in the study of another investigational product that may affect the outcome.